BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 4100224 · Received September 18, 2014

    Report

    Report Number
    1416980-2014-32104
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    August 26, 2014
    Report Date
    August 26, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS SERVICED ON-SITE BY A FIELD SERVICE TECHNICIAN. VISUAL INSPECTION, POWER ON SELF-TEST AND A REVIEW OF THE ALARM LOG WAS PERFORMED. DURING POWER ON SELF-TEST AND ALARM LOG REVIEW THE F-49 ALARM WAS FOUND; THE CAUSE OF THIS WAS DEVICE CONFIGURATION. TO CORRECT THE CONDITION, THE CONFIGURATION SETTINGS WERE RESET. THE DEVICE WAS SERVICED AND RESTORED TO A GOOD WORKING CONDITION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FLO-GARD INFUSION PUMP PRESENTED AN F-49 ALARM. IT WAS NOT SPECIFIED WHEN IN THE PROCESS THIS OCCURRED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578285 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1